BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFFINITY HFO W/TRILLIUM 511T

    MDR report key: 2667127 · Received July 24, 2012

    Report

    Report Number
    2184009-2012-00057
    Event Type
    Death
    Date Received
    July 24, 2012
    Date of Event
    June 29, 2012
    Report Date
    August 24, 2012
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMANCE ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION SHOWED NO OUTWARD SIGNS OF PHYSICAL DAMAGE OR ABNORMALITIES. BLOOD SIDE PRESSURE INTEGRITY TESTING WAS PERFORMED AT THREE LITERS PER MINUTE WITH TWENTY-THREE PSI OF BACK PRESSURE FOR TEN MINUTES. PRESSURE INTEGRITY TESTING SHOWED NO INTERNAL OR EXTERNAL LEAKS. GAS TRANSFER TESTING AT 7 LITERS PER MINUTE REVEALED OXYGEN AND CARBON DIOXIDE TRANSFER WERE SLIGHTLY LOWER THAN HISTORICAL AVERAGES. THE BLOOD SIDE PRESSURE DROP TESTED SLIGHTLY HIGHER THAN HISTORICAL AVERAGES. VENTILATING GAS PATH INTEGRITY TESTING WAS PERFORMED A 30 MMHG FOR 10 MINUTES. DURING THE VENTILATING GAS PATH INTEGRITY TESTING, THERE WERE NO LEAKS OBSERVED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. NO DESIGN OR MANUFACTURING ANOMALIES WERE FOUND DURING ANALYSIS THAT WOULD HAVE CAUSED/CONTRIBUTED TO THIS EVENT. ANALYSIS DID NOT IDENTIFY ANY FUNCTIONAL ANOMALIES OR DAMAGE TO THE PRODUCT. NO ANOMALIES WERE IDENTIFIED IN THE GAS PATH TEST. PERFORMANCE TESTING DETECTED SLIGHTLY LOWER GAS TRANSFER AS COMPARED TO HISTORICAL AVERAGES. IT IS EXPECTED THAT USED DEVICES WOULD HAVE SLIGHTLY LOWER GAS TRANSFER LEVELS THAN A NEW DEVICE AND THE TRANSFER LEVELS OF USED DEVICES CAN VARY DEPENDING ON THE USE CONDITIONS OF THE DEVICE. THE CUSTOMER'S REPORT OF VIRTUALLY NO GAS TRANSFER WAS NOT CONFIRMED BY THE ANALYSIS. THIS CONCLUSION WAS SUPPORTED BY REVIEW OF THE PUMP RECORDS BY A PERFUSION EXPERT. THE REPORTED ISSUE MAY HAVE BEEN CAUSED BY CLINICAL/PATIENT FACTORS OR ANOTHER COMPONENT OF THE PERFUSION CIRCUIT. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE PRODUCT HAS BEEN RETURNED AND CONTINUES TO UNDERGO EXTENSIVE ANALYSIS TESTING. UPON COMPLETION OF THE ANALYSIS, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 5-6 MINUTES AFTER ONSET OF BYPASS, THIS OXYGENATOR DID NOT OXYGENATE. BLOOD SATURATION OF OXYGEN CONTINUED TO DECREASE WITH ATTEMPTS TO INCREASE FLOW. PUMP RECORDS DID NOT REVEAL ANY ISSUES WITH ANTICOAGULATION. THE DEVICE WAS CHANGED OUT DURING THE PROCEDURE. AT THE TIME OF THE CHANGE OUT, THE PATIENT'S PRESSURE WAS LOW AND THE HEART WAS MASSAGED UNTIL THE PATIENT WAS BACK ON BYPASS. AFTER THE CHANGE OUT, BLOOD GASES RETURNED TO NORMAL. THE BLOOD PRESSURE REMAINED STABLE THROUGHOUT THE PROCEDURE. AT RE-WARMING MEDICATIONS WERE GIVEN TO KEEP THE BLOOD PRESSURE STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FOLLOWING THE PROCEDURE, THE PATIENT DID NOT REGAIN CONSCIOUSNESS AND DIED A WEEK LATER. THE CAUSE OF DEATH WAS NOT REPORTED. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT WAS (B)(6) AND WAS UNDERGOING A REDO CORONARY ARTERY BYPASS WITH A DOUBLE VALVE REPLACEMENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY HFO W/TRILLIUM 511T OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MEDTRONIC PERFUSION SYSTEMS 95215 12047476

    Patients

    Seq Age Sex Outcome Treatment
    1 Death